The following data is part of a premarket notification filed by Kfx Medical with the FDA for Appianfx Suture Anchor (6mm) (5mm) Appianfx Tissue Anchor.
| Device ID | K120841 |
| 510k Number | K120841 |
| Device Name: | APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | KFX MEDICAL 5845 Avenida Encinas, Suite 128 Carlsbad, CA 92008 |
| Contact | Gayle Hirota |
| Correspondent | Gayle Hirota KFX MEDICAL 5845 Avenida Encinas, Suite 128 Carlsbad, CA 92008 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-20 |
| Decision Date | 2012-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854044711 | K120841 | 000 |
| 10845854043806 | K120841 | 000 |
| 20653405987199 | K120841 | 000 |
| 30845854043787 | K120841 | 000 |
| 30845854044678 | K120841 | 000 |
| 10845854044698 | K120841 | 000 |
| 20653405987151 | K120841 | 000 |
| 20653405987168 | K120841 | 000 |
| 20653405987175 | K120841 | 000 |
| 20653405987182 | K120841 | 000 |
| 20845854043780 | K120841 | 000 |
| 20845854044671 | K120841 | 000 |
| 10845854044667 | K120841 | 000 |
| 10845854044681 | K120841 | 000 |
| 10845854044704 | K120841 | 000 |
| 10845854043790 | K120841 | 000 |